RRR Manufacturing Pty Ltd

RRR Manufacturing Pty Ltd specializes in automated external defibrillators (AEDs). Their primary product, the CellAED, is designed to deliver electrical shocks to help restore a normal heart rhythm in patients experiencing life-threatening cardiac arrhythmias like ventricular fibrillation or pulseless ventricular tachycardia. This device is intended for use in out-of-hospital cardiac arrest situations.

RRR Manufacturing Pty Ltd is based in Australia. Their devices, including the CellAED, must comply with local regulatory requirements, such as those set by the Therapeutic Goods Administration (TGA). While the company operates within Australia, its devices may also be subject to additional regulatory scrutiny depending on their intended markets, such as the EU.

The CellAED, an automated external defibrillator by RRR Manufacturing Pty Ltd, is listed in the eudamed database. This registry is used to track medical devices authorized for use within the European Union, reflecting compliance with EU regulatory requirements. Listing in eudamed is required for Class IIb devices, which the CellAED falls under.

The CellAED is classified as a Class IIb medical device under EU regulations. This classification is determined by factors such as the device’s intended purpose, risk level, and potential impact on patient safety. Class IIb devices are considered to pose moderate risks and require additional scrutiny, including conformity assessment procedures, to ensure their safety and performance before authorization.